NCT05365386

Efficacy and Safety of Tixel Treatment on Facial and/or Scalp Actinic Keratoses.

Evaluation of the Efficacy and Safety of a Thermal Fractional Skin Treatment System (TIXEL®) for the Treatment of Facial and / or Scalp Actinic Keratoses.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Novoxel Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the Efficacy and Safety of a thermal fractional skin treatment system (Tixel) for the treatment of facial and/or scalp actinic keratoses

Detailed description

Single-center, Prospective, Open-Label, with Before-After Study Design. Up to 25 subjects will be enrolled to the study to provide at least 20 evaluable subjects. Subjects will be examined to determine the severity and extent of actinic keratoses. All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4 weeks apart. Follow-up visits will be performed after the last treatment visit: 4 weeks (±7 days) and 12 weeks (±7 days). The inclusion criteria would be mild to moderate thickness confluent actinic keratoses located to scalp and/or face. Each subject will participate in the study for up to 20 weeks. Total study duration is estimated to be up to 12 months from enrollment of the first subject until last subject visit (including FUs).

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
DEVICE	Tixel C	This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.

Timeline

• Start date: 2022-05-17
• Primary completion: 2023-09-12
• Completion: 2023-09-12
• First posted: 2022-05-09
• Last updated: 2024-12-03
• Results posted: 2024-12-03

Locations

1 site across 1 country: Israel